Legal Lingo: What is a marketing authorisation, and why does it matter?

Being an aspiring commercial lawyer often means being confronted by complex, often abstract, concepts leading to an often impenetrable wall of jargon for students and trainees. Next up in our Legal Lingo series, which we've introduced to help break down this jargon, is a 101 on marketing authorisations.

There are many fantastic pharmaceutical innovations currently being developed to save lives and to keep us healthy. They range from simple tablets to complex personalised medicines.

Irrespective of how convincing the clinical trial data is, or how iron-clad the intellectual property rights are, before a medicinal product can be commercialised in the UK, the developer must obtain a marketing authorisation (MA). Without this, a developer can pour millions of pounds into the development of a medicinal product and never see a return on its investment.

In order to obtain a MA in the UK, the developer must demonstrate to the Medicines and Healthcare products Regulatory Agency (MHRA) that its medicine is safe, effective and of a sufficiently high quality. This means that products must undergo lengthy research and development programmes.

In relation to innovative medicinal products, this involves the conduct of preclinical testing (e.g., experiments involving the use of cell cultures and animals) and clinical trials (i.e., experiments involving human subjects). In relation to generic medicinal products, this involves referring to the MA application dossier of the innovative medicinal product of which it is a copy.

Clinical trials are generally organised into four phases, each of which is designed to look at a particular aspect of the investigational medicinal product. Clinical trials involve a sponsor (i.e., the developer), a principal investigator (PI) and trial site(s). The sponsor is responsible for the initiation, management, set-up and financing of the clinical trial, the PI is responsible for the overall care and management of the participants, and the site(s) ensures that the facilities are appropriate for the clinical trial to be carried out.

Once sufficient clinical data has been generated, the developer of an innovative medicinal product can submit an MA application to the MHRA. The assessors will look at whether the benefits of the medicinal product outweigh its risks. No medicinal products are completely risk-free; the specific risks posed by a medicinal product must be considered in a proper context. For example, a well-known side effect of chemotherapy is temporary hair loss. Whilst this is a traumatic experience, it is considered acceptable given the severity of the condition it is intended to treat. In contrast, this side effect would be unacceptable if caused by over-the-counter pain-relief.

If the MA is granted for an innovative medicinal product that is confirmed by the regulatory authority to contain a new active substance, it will benefit from an eight-year period of regulatory exclusivity. Once this period has expired, generic manufacturers can refer to the MA application dossier, instead of generating preclinical and clinical data themselves.

Even if the generic medicinal product is approved, it cannot be launched for a further two years until the innovator’s market exclusivity has expired. The total exclusivity period can be extended by a further year if one or more new indications, considered to be of significant benefit, are approved within the first eight years following the initial product approval. The regulatory framework governing regulatory data exclusivity seeks to ensure a fair balance between the protection of innovative companies and general interests that are served by the marketing of generic medicinal products.

After a medicinal product has been launched, the developer is required to monitor its long-term safety and effectiveness.

At Ropes & Gray, we provide strategic advice to clients of various sizes to manage every stage of the product lifecycle – from research to commercialisation (including pricing and reimbursement) and safety monitoring. We routinely work with teams in the US and Asia on commercially sensitive matters. If you want to find out more about the Life Sciences Regulation & Compliance practice in Europe, please click here.